Robotics & Automation Engineer - Manufacturing - Carpinteria
MiSolutions Consulting Carpinteria
Provide hands-on engineering support, trouble-shooting and maintenance of robotic and automated HMLV production floor equipment in regulated environment.
- Define, procure and support robotic and automated filling, labeling and packaging equipment (SOW, Functional Spec., FAT, SAT)
- Apply Project Management skills and tools to lead and support capital equipment and improvement projects.
- Resolve equipment failures with focus on root cause(s). Lead and assist with defining and implementing corrective and preventive actions, and resolution to audit findings.
- Prepare, complete and support validations (IQ/OQ/PQ) to meet applicable FDA and regulatory requirements.
- Bachelor Degree in Mechanical, Electrical, Robotics, Automation, or other relevant Engineering & Technology disciplines with 5+ years of experience, or equivalent combination of education and experience.
- Prior hands-on working experience with Robotics & Automation, PLCs, HMIs, Vision Systems, Servos, and Labelers
- Prior experience maintaining robotic & automated equipment
- Prior experience with process/equipment validation: writing documentation and execution - IQ, OQ, PQ
- Strong technical, project management and documentation skills
- Self-starter, highly organized, complex problem solver with technical, detail-oriented mindset and strong analytical and communication skills
- Demonstrated ability to work in a regulated environment
- Knowledge of FDA QSR requirements, ISO 13485, or other recognized international quality system standards
- Prior experience in working with and/or managing suppliers and/or subcontractors
- Experience with DI water systems, cold room management, central monitoring systems
- Experience with FMEA, DOE, SPC
- CAD, SolidWorks experience
- Experience with SAP, Agile, and Electronic Batch Records
- Prior hands-on experience with programming Fanuc and Denso robots, Omron and Allen Bradly PLC, HMIs, Cognex Vision Systems, Zebra, Sato and DataMax Labelers
- Knowledge of Industry 4.0, AI, predictive analytics and touchless transactions.
Robotics & Automation
Project Management - Capital Equipment
Validation/ISO Documentation- 5+ years exp. with Robotics & Automation - Hands on experience working with automated manufacturing equipment
- Project management experience (Capital Equipment) – replacing aging equipment
- Validation experience – ISO Documentation experience (can train on this but must be willing to be trained on it)
- Continuous improvement/Digitalization
o ROI
o Process Improvements
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